anastrozole

Generic: anastrozole

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name anastrozole
Generic Name anastrozole
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

anastrozole 1 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-075
Product ID 50268-075_4cb0acb4-c462-984f-e063-6294a90abe7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA079220
Listing Expiration 2027-12-31
Marketing Start 2019-10-11

Pharmacologic Class

Established (EPC)
aromatase inhibitor [epc]
Mechanism of Action
aromatase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268075
Hyphenated Format 50268-075

Supplemental Identifiers

UNII
2Z07MYW1AZ
NUI
N0000175563 N0000175080

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name anastrozole (source: ndc)
Generic Name anastrozole (source: ndc)
Application Number ANDA079220 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-075-15) / 1 TABLET in 1 BLISTER PACK (50268-075-11)
source: ndc

Packages (1)

50268-075-15 50 BLISTER PACK in 1 BOX (50268-075-15) / 1 TABLET in 1 BLISTER PACK (50268-075-11)

Ingredients (1)

anastrozole (1 mg/1)

Linked Drug Pages (1)

ANASTROZOLE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4cb0acb4-c462-984f-e063-6294a90abe7c", "openfda": {"nui": ["N0000175563", "N0000175080"], "unii": ["2Z07MYW1AZ"], "spl_set_id": ["94a46579-0d79-89c7-e053-2995a90a6467"], "pharm_class_epc": ["Aromatase Inhibitor [EPC]"], "pharm_class_moa": ["Aromatase Inhibitors [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-075-15)  / 1 TABLET in 1 BLISTER PACK (50268-075-11)", "package_ndc": "50268-075-15", "marketing_start_date": "20191011"}], "brand_name": "ANASTROZOLE", "product_id": "50268-075_4cb0acb4-c462-984f-e063-6294a90abe7c", "dosage_form": "TABLET", "pharm_class": ["Aromatase Inhibitor [EPC]", "Aromatase Inhibitors [MoA]"], "product_ndc": "50268-075", "generic_name": "ANASTROZOLE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ANASTROZOLE", "active_ingredients": [{"name": "ANASTROZOLE", "strength": "1 mg/1"}], "application_number": "ANDA079220", "marketing_category": "ANDA", "marketing_start_date": "20191011", "listing_expiration_date": "20271231"}